IRCCS Ospedale Galeazzi-Sant'Ambrogio
Milan, MI, 20157, Italy
Location status: Recruiting
Recruiting
NCT Number: NCT07250126
3D Biomimetic Spine Unit Model Through the Integration of Bioprinting and Transcriptomics (CDP-SUBT)
The general objective of this project is to define the transcriptional profile of primary human cells derived from the nucleus pulposus (NP), annulus fibrosus (AF), and cartilaginous endplate (CEP), and to use this information as a reference to assess the biological relevance of a biomimetic spinal unit model obtained through bioprinting. By developing an in vitro model of human origin that incorporates key components of the spinal unit and applying transcriptional analyses to both native cells and their counterparts recovered from the 3D construct, the study will evaluate how accurately the bioprinted model reproduces the identity and heterogeneity of the native discal environment.
Recruiting
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Conditions
Age range
30 year–70 year
Sex eligibility
All sexes
Study type
Observational
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Signature of the Informed Consent for the study
- Age 30-70 years (included)
- Pfirrmann grade III-V
- Need to undergo spinal surgery
Exclusion criteria
- Presence of HIV, HBC, HCV or TPHA infection
Treatment and study plan
Primary outcomes
-
Discovery of Tissue-Specific Molecular Markers in Intervertebral Disc Cellular Populations
Time frame: From enrollment to data analysis (24 months)
To identify genes that are specifically upregulated in one of the three intervertebral disc cellular populations-nucleus pulposus (NP), annulus fibrosus (AF), and cartilaginous endplate (CEP)-through comparative gene expression analysis of paired samples obtained from the same donors. This aim seeks to determine tissue-specific molecular markers that will be subsequently applied to the characterization of bioprinted intervertebral disc models.
Sponsors and collaborators
Lead sponsor
I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
Other
Registry information
Acronym: CDP-SUBT
Important dates
- Study start
- 2025
- Primary completion
- 2027
- Study completion
- 2027
- First posted
- Nov 26, 2025
- Registry last updated
- Nov 26, 2025
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.